510(k) K944909

WAHL FRESH FACE by Wahl Clipper Corp. — Product Code IRO

K944909 is an FDA 510(k) premarket notification submitted by Wahl Clipper Corp. for the device "WAHL FRESH FACE". The FDA issued a decision of Substantially Equivalent on May 8, 1995. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Wahl Clipper Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1995
Date Received
October 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vibrator, Therapeutic
Device Class
Class I
Regulation Number
890.5975
Review Panel
PM
Submission Type